NCT05685290

Brief Summary

The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

January 3, 2023

Last Update Submit

April 5, 2024

Conditions

Keywords

Pediatric oncologyIntravenous Catheter Placementnursingrandomized controlled study

Outcome Measures

Primary Outcomes (1)

  • Catheterization Description Form

    The form contains the catheter information regarding the children. It includes 7 questions including the time elapsed since the last vascular access, causes of catheter removal complications (infiltration, vascular damage, etc.), IV catheter location, IV catheter size (number), and peripheral vein where the catheter was placed. Primary endpoint of the study is Catheterization Description Form.

    Immediately after the procedure.

Study Arms (2)

Intervention group

EXPERIMENTAL

Pushing with saline technique

Other: Pushing with saline technique

Control group

ACTIVE COMPARATOR

Traditional method

Other: Traditional method

Interventions

Peripheral venous catheter placement by pushing with saline technique

Intervention group

Peripheral venous catheter placement with the traditional method by nurses in the clinic routinely.

Control group

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The child who ages of 0-17.
  • The child's need for peripheral IV catheter placement for treatment.
  • A score of 4 or higher on the Difficult Intravenous Access Score for Children

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meltem Gürcan

Konyaalti, Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (1)

  • Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.

Study Officials

  • Sevcan ATAY TURAN, PhD

    Assistant Professor

    STUDY DIRECTOR
  • Ayla KAYA, PhD

    Research Assistant

    STUDY DIRECTOR
  • Elif GÜLER, PhD

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be blinded to group allocation and randomization process. Additionally they will be blinded for interventions.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 17, 2023

Study Start

July 17, 2023

Primary Completion

November 30, 2023

Study Completion

January 15, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations